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临床试验/NCT04216875
NCT04216875已完成不适用

Optimisation of Treatment of Chronic Patients With Diabetes Mellitus Type 2 in Primary Care (Qualiccare Begleitforschung Zur Optimierung Der Behandlung Von Chronischen Patienten Mit Diabetes Mellitus Typ 2 in Der Grundversorgung)

QualiCCare1 个研究点 分布在 1 个国家目标入组 738 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
QualiCCare
入组人数
738
试验地点
1
主要终点
Change in score result before and after the introduction of the diabetes score criteria for treatment of diabetes patients in the primary care setting

研究概览

简要总结

This observational study intends to evaluate the use and adherence of different types of primary care practices to the diabetes criteria-protocol (diabetes score), developed by the Swiss Society of Endocrinology and Diabetology. This diabetes score comprises visits to the doctor, lifestyle consultations, clinical measures such as blood pressure, cholesterol or blood sugar, as well as measures concerning the prevention of secondary complications like kidney, eye or feet issues. The participating primary care practices need to treat 80% of their diabetes patients (their "diabetes population") in accordance to the score-criteria. In addition to the adherence to the eight score-criteria, the practices are required to also document statistically if their diabetes patients get the following medication: oral antidiabetics, insulin, blood pressure medication, statins and / flu vaccine. As this observational study is and before-and-after study, the primary care practices need to document for each of their diabetes patients the care they provided in the year before the introduction of the score-criteria and in the year following their introduction. Participating primary care practices ask their diabetes patients' consent to the documentation and anonymous transmittance of their data. Data evaluation is anonymous and on a population-based level (as opposed to individual-based). The hypothesis of the study is to prove that the implementation of evidence-based measures, such as a diabetes score can increase the treatment quality of diabetes patients in primary care practices and this increase is independent of the primary care practice structure in which it is applied.

详细描述

Information of the primary care practices regarding the background and goal of the project by means of a letter and informative documentation.

Recruitment of primary care practices, divided into three different practice organisations (individual practices and group practices run on a private basis and with financial autonomy, as well as forms of joint practices with employed physicians without financial autonomy).

A signed contract between QualiCCare and participating primary care practices regulates the collaboration.

Procedure:

A baseline documentation takes place retrospectively from the training/workshop for the past 12 months, and a second, prospective documentation of the treatment is done during the following 12 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • all patients in the primary care practice with a diabetes diagnosis, meaning their patient record shows that the patient either had an HbA1c value higher than 6.4 percent, takes insulin or oral antidiabetics and is treated at least during nine months in the participating primary care practice.

排除标准

  • treatment in participating primary care practice during less than nine months (due to change of primary care provider, death, diabetes treatment solely by specialist);
  • patients who do not give their patient consent to participate in study;
  • patients whom the primary care provider excludes from study due to frailty, end of life or other reasons.

结局指标

主要结局

Change in score result before and after the introduction of the diabetes score criteria for treatment of diabetes patients in the primary care setting

时间窗: one year

The change is measured at baseline, before the introduction of the diabetes score criteria and one year after the introduction. There are 8 score criteria for the good diabetes management in primary care (such as 1x/y lifestyle consultation, 1x/foot control, etc). Each criteria gets a certain number of points if 80% of the participating patients are treated in accordance to the given criteria. In total, a maximum of 100 points can be achieved. The objective is to achieved a minimum of 70% (= 70 points).

次要结局

  • Evaluation of feasibility of the implementation of the diabetes score criteria in different primary care practice types(one year)
  • Comparison of the diabetes treatment in regards to the different primary care settings(one year)
  • Evaluation of practice tool used for the documentation and evaluation of the diabetes score(one year)

研究者

发起方
QualiCCare
申办方类型
Other
责任方
Sponsor

研究点 (1)

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